| name | monitor-data-integrity |
| title | 監測資料完整性 |
| description | Design and operate a data integrity monitoring programme based on ALCOA+ principles. Covers detective controls, audit trail review schedules, anomaly detection patterns (off-hours activity, sequential modifications, bulk changes), metrics dashboards, investigation triggers, and escalation matrix definition. Use when establishing a data integrity monitoring programme for GxP systems, preparing for inspections where data integrity is a focus area, after a data integrity incident requiring enhanced monitoring, or when implementing MHRA, WHO, or PIC/S guidance. |
| author | pjt222 |
| author_url | https://github.com/pjt222/agent-almanac/tree/main/i18n/wenyan-lite/skills/monitor-data-integrity |
| license | MIT |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | general |
| practice | life-sciences |
| language | zh |
監測資料完整性
依 ALCOA+ 原則與異常偵測，設計並運行貫穿經驗證系統之資料完整性持續監測計劃。
適用時機
- 為 GxP 系統建立資料完整性監測計劃
- 法規檢查在即，而資料完整性為其重點
- 資料完整性事件之後，須加強監測
- 既有資料完整性管制之定期檢視
- 實施 MHRA、WHO 或 PIC/S 之資料完整性指引
輸入
- 必要：在範圍內之系統及其 ALCOA+ 風險概況
- 必要：適用之指引（MHRA Data Integrity、WHO TRS 996、PIC/S PI 041）
- 必要：每系統當前之審計追蹤能力
- 選擇性：先前之資料完整性發現或法規觀察
- 選擇性：既有監測程序或指標
- 選擇性：用戶存取矩陣與角色定義
步驟
步驟一：評估當前 ALCOA+ 態勢
對每系統依 ALCOA+ 各原則評之：
# Data Integrity Assessment
## Document ID: DIA-[SITE]-[YYYY]-[NNN]
### ALCOA+ Assessment Matrix
| Principle | Definition | Assessment Questions | System 1 | System 2 |
|-----------|-----------|---------------------|----------|----------|
| **Attributable** | Who performed the action and when? | Are all entries linked to unique user IDs? Is the timestamp system-generated? | G/A/R | G/A/R |
| **Legible** | Can data be read and understood? | Are records readable throughout retention period? Are formats controlled? | G/A/R | G/A/R |
| **Contemporaneous** | Was data recorded at the time of the activity? | Are timestamps real-time? Are backdated entries detectable? | G/A/R | G/A/R |
| **Original** | Is this the first-captured data? | Are original records preserved? Is there a clear original vs copy distinction? | G/A/R | G/A/R |
| **Accurate** | Is the data correct and truthful? | Are calculations verified? Are transcription errors detectable? | G/A/R | G/A/R |
| **Complete** | Is all data present? | Are deletions detectable? Are all expected records present? | G/A/R | G/A/R |
| **Consistent** | Are data elements consistent across records? | Do timestamps follow logical sequence? Are versions consistent? | G/A/R | G/A/R |
| **Enduring** | Will data survive for the required retention period? | Is the storage medium reliable? Are backups verified? | G/A/R | G/A/R |
| **Available** | Can data be accessed when needed? | Are retrieval procedures documented? Are access controls appropriate? | G/A/R | G/A/R |
Rating: G = Good (controls adequate), A = Adequate (minor improvements needed), R = Remediation required
每系統皆有評級之 ALCOA+ 評估，且各原則皆有具體發現。
若某系統不可評估（如無審計追蹤能力），標之為關鍵缺口，需即刻補正。
